Device Engineer / Scientist – Design Verification & Medical Devices | ???? Device Engineer / Scientist (m/w/d) Design Verification & Medical Devices (MDR/FDA)
expertum GmbH
Job Summary
As a Device Engineer or Scientist, you will play a pivotal role in the development and verification of medical and combination products. Your day-to-day responsibilities involve planning, executing, and coordinating design verification activities, including the creation of test strategies and regulatory reports. You will ensure strict compliance with international standards such as MDR and FDA regulations (21 CFR 820.30) throughout the product lifecycle. As a key member of interdisciplinary teams, you will act as an Evaluation Engineer, collaborating closely with departments like Quality Assurance, Risk Management, and Usability Engineering to facilitate product approvals. The position requires a degree in a Life Sciences or Engineering discipline and proven experience in regulated development environments. This role is highly attractive due to its focus on innovative medical technology, a hybrid working model offering flexibility, and the opportunity to work within a prominent pharmaceutical company, supported by comprehensive social benefits and professional development opportunities.
Required Skills
Education
Completed degree in a Life Sciences discipline (e.g., Medical Technology, Biotechnology, Pharmacy, Engineering, or Natural Sciences).
Experience
- Several years of professional experience in the regulated development of medical or combination products
- Proven experience in the planning, execution, and documentation of design verification processes
- Professional experience in cross-functional team collaboration and project coordination
Languages
Additional
- Work permit for Germany required. The role is based in Ingelheim am Rhein with a hybrid work model (2-3 days home office per week).
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